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510(k) Data Aggregation

    K Number
    K992252
    Device Name
    LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
    Manufacturer
    CHEMICON INTL., INC.
    Date Cleared
    1999-08-10

    (35 days)

    Product Code
    LYF
    Regulation Number
    866.3780
    Type
    Special
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Light Diagnostics Pneumocystis carinii DFA intended use is an in vitro procedure for the detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens including sputum, bronchoaveolar lavage, and lung biopsy.

    Device Description

    Not Found

    AI/ML Overview

    I am unable to extract the requested information from the provided document. The document is a 510(k) clearance letter from the FDA for a device called "Light Diagnostics Pneumocystis carinii DFA." This letter primarily addresses regulatory approval and does not contain details about specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

    To get the information you need, you would typically look for a separate clinical study report, a submission summary, or the relevant sections within the 510(k) submission itself, which are not included in these pages.

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